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The General Pharmaceutical Council (GPhC) has raised concerns over the rising risks related to online pharmacy services. It revealed over 30 per cent of its open Fitness to Practise (FtP) cases were related to online pharmacy, which is disproportionate to the sector of the market that online services occupy. The regulator has advised pharmacists and pharmacy owners providing online services that they should "not work with online providers who try to circumvent the regulatory oversight put in place within the UK to ensure patient safety". In the past five months, the Council has imposed seven interim orders on the registration of pharmacists who have worked for or with online prescribing services - after identifying serious concerns with their practice. It said: "These pharmacists were working as pharmacist independent prescribers for online services or were dispensing medicines prescribed online. Some of these pharmacists were the Responsible Pharmacist (RP) or the Superintendent Pharmacist (SP)."

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

Vitamin b12 called cobalamine, important for vital functions in body, like maintenance. Deficiency cause malnutrition and digestion problems. Treatments including supplements, injections and vitamins regulatory measures.

The General Pharmaceutical Council (GPhC) has published a new strategy pledging to deliver equality, improve diversity and foster inclusion in all aspects of its work. The strategy was updated after a public consultation held between April and July. It's key themes are: To make regulatory decisions that are demonstrably fair, lawful, and free from discrimination and bias. To use our standards to proactively help tackle discrimination and to make sure everyone can access person-centred care, fostering equality of health outcomes.To lead by example and demonstrate best practice within our organisation, holding ourselves to the same high standards we expect of others. GPhC chair Nigel Clarke said having a strategy is vital as the pandemic has exposed "the scope and scale of inequities in society, in healthcare outcomes and in pharmacy." "Inequality and exclusion are bad for people's health. Therefore, this strategy is fundamental to our core purpose as a regulator and our vision for safe and effective pharmacy care at the heart of healthier communities."

To complete the evaluations of Lateral Flow Device (LFD) test kits, the UK Health Security Agency (UKHSA) will approach pharmacies and send 15 combined kits to pharmacies in December. The combined kits will contain a standard LFD pack, one PCR test along with comprehensive instructions. For the evaluation, a part of meeting Medicines and Healthcare products Regulatory Agency (MHRA) obligations, UKSHA needs "dual swabbing through the community pharmacy Covid-19 lateral flow device distribution service." Pharmacies receiving these kits need to finish the current open carton of LFD packs and then open the next standard carton. Pharmacy negotiator PSNC has advised pharmacies to be mindful of "the expiration date of the kit and ensure these are handed out in sufficient time."

The Association of the British Pharmaceutical Industry (ABPI) has supported the Department of Health and Social Care's recommendation to 'aggressively expedite and roll out new medicines' that have gone through trials. The ABPI welcomes government report on cancer services in England and the opportunity it provides to refocus how the pharmaceutical industry, NHS and government can improve the lives of cancer patients. David Watson, executive director, Patient Access at the ABPI, said: "Despite progress, UK patients still have much worse five-year survival rates for many cancers than those in similar nations. Early diagnosis and fast and equal access to the latest treatments for all patients is key to reversing poor trends in NHS cancer care. "We are pleased that the report reflects concerns about variable access to cancer medicines. We support the Committee's recommendations to 'aggressively expedite and roll out new medicines' that have gone through trials and to ensure regulatory innovation results in swift uptake in the UK.

The General Pharmaceutical Council (GPhC) has launched a new draft 'Equality Guidance' for pharmacies to tackle discrimination and make sure that everyone can access safe and effective person-centred pharmacy care. GPhC's consultation is seeking views on "the structure and language of the guidance, if anything is missing and the impacts on patients and members of the public, pharmacy staff, pharmacy owners, and individuals or groups sharing any of the protected characteristics." The regulator said the draft guidance is designed to support pharmacy owners to: demonstrate that they are meeting our standards for registered pharmacies fulfil their legal and regulatory duties in relation to equality help protect the rights of individuals advance equal opportunities for staff, patients and the wider public help improve the experience and healthcare outcomes of patients and members of the public.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine. The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription. Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022. It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses. After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately. Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing. "Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA. The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.

Britain's biotech firm Avacta Group on Monday (January 10) announced halting sales of its Covid-19 rapid antigen lateral flow test AffiDX to replace antibodies in the device and increase its ability to diagnose the Omicron variant. The company stated that AffiDX is capable of detecting Omicron when the virus is present in high numbers in samples, but the sensitivity of the test reduces at lower viral loads. The performance of all rapid antigen tests came under scanner in wake of a large number of mutations in the Omicron variant. AffiDX contains both a proprietary Affimer reagent and a commercially available antibody. The Affimer reagent detects the Omicron variant with the same sensitivity as the Delta variant, and performance of the antibody is paired with the Affimer reagent in the test. This has been affected by the additional Omicron mutations, the firm said. Alastair Smith, chief executive of Avacta Group, said: "Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX® lateral flow antigen test. We have, of course, been unable to market the product in the UK since October 2021, as the product continues to await approval under the new CTDA regulatory process.

UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old. The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22). Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data. These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said. Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

Amendments to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 along with introduction of a new type of pharmaceutical service come into effect from Tuesday (December 21) and from January 1, 2022. PSNC will be consulted on the new type of enhanced service - the National Enhanced Service (NES), where NHS England and NHS Improvement (NHSE&I) commissions an enhanced service with a service specification that sets standard conditions nationally. Other amendments to the regulations include: Changes in the contractors' terms of service, allowing NHSE&I to introduce a pandemic response programme, by which contractors are required to have various premises and other arrangements for responding to a pandemic. An alternative route to supply pandemic treatments, via a listed prescription items voucher (LPIV). This is a further option for the community pharmacy for supply of treatments or medicines during or in anticipation of pandemic disease;

Hundreds of children in England are set to benefit from a treatment for cystic fibrosis - Kaftrio, after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed an extension to its licence. With the licence extension, more than 1,300 children in England with cystic fibrosis, aged six to 11, are newly eligible for this treatment, which improves lung function and improves overall quality of life of patients. Earlier, Kaftrio was only licensed for those aged 12 and above. British patients were the first in Europe to benefit from Kaftrio, when NHS England secured a landmark deal in June 2020. NHS chief executive Amanda Pritchard said: "Since NHS staff delivered one of the fastest rollouts of Kaftrio in the world just over a year ago, the lives of thousands of patients with cystic fibrosis have been transformed. "Innovative treatments like Kaftrio are life-changing for patients and their families, and that is why the NHS has done all it can since we secured the deal for Kaftrio to ensure patients benefit as soon as possible.

Pharmaceutical Services Negotiating Committee (PSNC) has asked the government and the NHS to give more support to all community pharmacies as they gear up for "an extremely challenging winter period." During talks with NHS England and NHS Improvement (NHSE&I) and the Department of Health and Social Care (DHSC) last week, PSNC highlighted that contractors are already under pressure because of workforce crisis, capacity issues and escalated staffing costs. all these factors could pose a bigger challenge during the busy winter season, it said. Though PSNC supported the government's aim on booster vaccinations and approval of more pharmacy sites, it expressed concerns over the impact of the vaccination drive on all community pharmacies. To ease the pressure on pharmacies, the negotiator has sought additional support through regulatory measures, the removal of administrative burdens and changes to the current Pharmacy Quality Scheme (PQS).

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to ensure appropriate patient counselling takes place and patients are aware of the missing information on the patient information leaflet (PIL) of Decongestant Tablets and Decongestant with Pain Relief Tablets. The advise came after Boots has identified an error with the printed PIL provided with batches of the tablets. Check the website for more information.

The Medicines and Healthcare products Regulatory Agency has issued a class 2 medicines recall notice for Olopatadine USV 1mg/ml eye drops. Specific batches of this product are being recalled by USV UK Limited as a precautionary measure due to the identification of out of specification results for impurities during routine stability testing. USV UK Limited are recalling the affected batches as a precautionary measure due to out of specification results for impurities during routine stability testing.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

The Fitness-to-Practise Committee of the General Pharmaceutical Council has issued a three-month suspension to Mohammed Roohul Haque (Reg No: 2226084), a locum pharmacist, due to incidents of workplace sexual misconduct. According to the determination document issued by the regulatory body, Haque undertook the position of a locum pharmacist at Hollowood Chemists on July 12. It was during this period that he encountered the dispenser (referred to as the "complainant"), a 40-year-old co-worker at the pharmacy, for the first instance. Following this initial meeting, he proceeded to engage in making explicit sexual comments. During the lunch break of the pharmacy's second dispenser, Haque asked the dispenser, who had lodged the complaint, to review photographs displayed on his mobile phone, depicting renovations being carried out at his residence. The initial images focused on the ongoing renovation activities. However, he later switched to displaying a full-screen photograph of his erect penis, the document said. Despite the fact that the dispenser promptly distanced herself, Haque persisted in discussing the photograph with her. He went so far as to apologise, and even asked if she had managed to closely observe the picture.

The regulatory amendments proposed will enable pharmacists to dispense medicines in their original packaging for private prescriptions starting this Autumn, according to the Department of Health and Social Care. In the recently published draft OPD regulations, the DHSC has indicated that the alterations, permitting pharmacists to vary the dispensed quantity by up to 10 per cent to avoid splitting medicine packs, will be implemented for private prescriptions 'immediately upon the enforcement of the Human Medicines Amendment Regulations in the autumn,' as highlighted in a briefing by Community Pharmacy England. CPE stated that the regulations related to NHS prescriptions will come into effect when the pharmaceutical terms of service regulations expressly apply the OPD amendments. Moreover, new directive mandating the dispensing of sodium valproate products solely in their original packaging (except when an assessment of risk necessitates an alternative approach) will align with the rollout of the private prescription regulations during the autumn. CPE further noted that these regulations are currently in draft, indicating that they are not currently in effect and may undergo revisions prior to their implementation.